Roche has announced that a new injectable ( subcutaneous ) formulation of Herceptin ( Trastuzumab ) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease.
The approval is for both early and later stages of treatment.
The European Commissions approval was based on data from the HannaH study which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy ( pathological complete response, pCR ) to Herceptin administered intravenously in women with HER2-positive early breast cancer and resulted in non-inferior Trastuzumab plasma levels. Overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting. No new safety signals were identified.
Herceptin is a humanised monoclonal antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when it is overexpressed. The mode of action of Herceptin activates the bodys immune system and suppresses HER2 signalling to target and destroy the tumour.
Since Herceptin was first approved in 1998, this targeted medicine has been used to treat more than 1.3 million patients worldwide. Given on its own as monotherapy, as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve overall survival, response rates and disease-free survival while maintaining quality of life in women with HER2-positive breast cancer.
Eligibility for Herceptin treatment is determined by a diagnostic test, saving time from the outset by identifying those patients who would derive greater benefit from alternative treatments.
The subcutaneous form of Herceptin is a ready-to-use liquid formulation that is administered as a 600 mg/5 ml fixed dose every three weeks. This simplifies healthcare procedures by removing the need for reconstitution or dose calculation according to the body weight of individual.
A loading dose is not required when using subcutaneous administration.
The subcutaneous formulation uses technology developed by Halozyme Therapeutics, that temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the 5 ml volume of the subcutaneous formulation of Herceptin to be rapidly dispersed and absorbed over a greater area. ( Xagena )
Source: Roche, 2013